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Correlation Between Body Mass Index and Progressive Grafted Bone in Cleft Patients

Correlation Between Body Mass Index and Progressive Bone Mineral Density in Cleft Patients After Secondary Alveolar Bone Grafting

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05002920
Enrollment
39
Registered
2021-08-12
Start date
2021-01-25
Completion date
2021-07-04
Last updated
2021-08-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bone Graft; Complications, Cleft Lip and Palate

Keywords

alveolar bone grafting, body mass index, bone mineral density, cone beam computed tomography

Brief summary

The cleft patients received alveolar bone graft(ABG) for alveolar defect. Body mass index (BMI) was measured for each patients when receiving ABG. Bone mineral density was measured by Cone-Beam CT at two time-points: post-ABG six months, and post-ABG two years. The study was to analyze the correlation between BMI and post-operative bone mineral density.

Detailed description

Although childhood obesity is a growing issue, the association between BMI and the progressive bone mineral density (BMD) in grafted tissue after secondar alveolar grafting (ABG) remains little reviewed. This study compared the correlation between BMI and the progressive BMD after ABG procedure. Thirty-nine patients with unilateral or bilateral clefts were enrolled. ABG was performed at mixed-dentition age. Patient were classified into underweight, normal weight, and overweight or obese based on age- and sex-adjusted BMI. BMD was expressed in Hounsfield unit (HU) on cone-beam computed tomography (CBCT), which was obtained at 6 months (T1) and 2 years (T2) postoperatively. Calibrated BMD (HUgrafted tissue/HUpogonion¬, BMDc) was used for further analysis.

Interventions

PROCEDUREalveolar bone grafting

the surgery of alveolar bone graft for alveolar defect in cleft patients

Sponsors

Chang Gung Memorial Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
8 Years to 10 Years
Healthy volunteers
No

Inclusion criteria

* nonsyndromic unilateral or bilateral cleft lip and alveolus with or without palate patients * received secondary ABG at Chang Gung Craniofacial Center * received team managements based on our current treatment protocol for cleft lip and palate

Exclusion criteria

* syndromic cleft * patients with failed grafted tissue

Design outcomes

Primary

MeasureTime frameDescription
bone mineral densitypost-ABG six monthsmeasuring the bone density from cone beam CT

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026